Medical Device Academy, Inc.

Medical Device Academy, Inc. is a quality and regulatory consulting firm specializing in FDA submissions and compliance for medical device manufacturers. The company operates with a 10-person virtual team focused on helping small device companies navigate FDA 510(k) submissions, pre-submissions, and quality system implementation.

The firm specializes in FDA eSTAR template preparation, ISO 13485 and MDSAP compliance, and comprehensive quality system auditing. They offer structured consulting services with typical 510(k) preparation costs of $17,500 and maintain an extensive training library including a lead auditor training course and a 510(k) course series. Their approach emphasizes efficient project management through weekly 30-minute meetings and color-coded planning tools.

Medical Device Academy provides global regulatory support including FDA US Agent services, CE Marking preparation, and Canadian License applications. They maintain an active YouTube channel with 9.8K subscribers and have published specialized training materials including "How to prepare your 510k in 100 days."

Medical Device Academy is positioned for companies prioritizing structured processes and regulatory education alongside consulting services. Their fixed-fee 510(k) preparation model at $17,500 provides budget certainty, while their emphasis on pre-submission meetings helps avoid costly testing delays.

Companies benefit from access to continuously updated training materials and a consultant team that operates virtually, potentially offering scheduling flexibility. The firm's focus on eSTAR templates and small business FDA fee guidance demonstrates current regulatory knowledge.

Medical Device Academy exclusively serves the medical device manufacturing sector with deep expertise in FDA regulatory pathways. They specialize in Class I, II, and III medical device submissions, cybersecurity guidance for connected devices, and quality system compliance across FDA 21 CFR Part 820, ISO 13485:2016, and MDSAP requirements. Their blog covers specialized medical device topics including design controls, CAPA systems, human factors engineering, and software as a medical device (SaMD) regulations.

Startups and small medical device manufacturers preparing their first FDA 510(k) submission or establishing quality systems for the first time. Companies with time-critical market entry needs who value structured project management, transparent pricing, and access to regulatory training resources alongside consulting services.